A Multi-centre, International 14-day Inception Cohort Study of Severe Acute Respiratory Infections on the Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- 60-day-inhospital death
研究概览
简要总结
IC-GLOSSARI (The Intensive Care GLObal Study on Severe Acute Respiratory Infection) is a multicentre, prospective, observational,14-day inception cohort study designed and conducted by the ESICM Trials Group to investigate the epidemiology and microbiology profiles of ICU-SARI, document commonly used treatment and monitoring strategies, measure current outcomes and identify potential topics for multidisciplinary studies ranging from interventional clinical trials to fundamental mechanisms of disease.
The purpose of this study is to answer the following questions:
What is the frequency and disease burden of SARI for ICU's worldwide? What are the aetiologies of ICU SARI? How are SARI patients diagnosed and managed in the ICU? What is the outcome from SARI in the ICU? Is there a difference in outcomes from SARI depending on the aetiology of the disease? Can we identify high-risk categories of SARI that could constitute a defined population for an interventional study?
详细描述
Following the recent outbreaks of SARS and H1N1 influenza infections, there has been a significant interest in the surveillance of patients with severe acute respiratory infections (SARI), defined by the World Health Organisation (WHO) as an acute respiratory illness of recent onset (within 7 days) manifested by fever (≥ 38°C), cough, and dyspnea requiring overnight hospitalization.
Whereas this definition of SARI may prove practical to mount sentinel SARI surveillance systems, it is unlikely to provide relevant information for intensive care physicians regarding the nature of infections, the spectrum of severity, or the diagnostic and treatment strategies used for the subset of patients that are ultimately admitted to intensive care units. Only a subset of the SARI patients as defined by WHO will require ICU admission for oxygen therapy or positive pressure ventilation; a smaller subset will develop an acute respiratory distress syndrome (ARDS) and an even smaller proportion will require adjunctive treatments such as nitric oxide, ECMO, use of prone position or high frequency oscillation (HFO). Obtaining accurate information on the epidemiology of ICU-SARI and how these patients are currently diagnosed and treated will help us to understand the factors associated with progression from acute respiratory infections to the most severe forms of critical illness such as ARDS, septic shock, or multiple organ failure.
We thus aim to undertake a prospective, observational, inception cohort study to investigate the epidemiology and microbiology profiles of ICU-SARI, document commonly used treatment and monitoring strategies, measure current outcomes and identify potential topics for multidisciplinary studies ranging from interventional clinical trials to fundamental mechanisms of disease.
Fourteen day international inception cohort study of adult (≥18 years) patients presenting with SARI on admission to the ICU (ICU-SARI).
The study will be performed over 4 weeks. Each centre will include patients for 2 weeks, one in November and the other in January.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to an Intensive Care Unit due to respiratory tract infection
- •Recent onset (within 7 days prior to ICU admission) of at least one of the following manifestations: dyspnea, fever (≥ 38°C, possible, probable or microbiologically confirmed respiratory tract infection
排除标准
- •Patients less than 18 years of age
- •Patients in whom the pneumonia cough and dyspnoea have been present for over seven days
- •Any patients who are on invasive (through an endotracheal tube) mechanical ventilation prior to admission for any reason other than general anaesthesia for surgical procedures.
- •Any patients previously included in the study during the same study period
结局指标
主要结局
60-day-inhospital death
时间窗: One week
次要结局
- ICU mortality.(One week)